Last update 19 Sep 2024

Donidalorsen

Overview

Basic Info

Drug Type
ASO
Synonyms
Donidalorsen Sodium, IONIS-PKK-LRx, IONIS-PKKRX
+ [2]
Target
Mechanism
KLKB1 inhibitors(Plasma kallikrein inhibitors)
Active Indication
Inactive Indication-
Originator Organization
Active Organization
Inactive Organization-
Drug Highest PhasePhase 3
First Approval Date-
RegulationOrphan Drug (EU)

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Hereditary AngioedemaPhase 3
PL
03 Dec 2021
Hereditary AngioedemaPhase 3
BG
03 Dec 2021
Hereditary AngioedemaPhase 3
NL
03 Dec 2021
Hereditary AngioedemaPhase 3
IL
03 Dec 2021
Hereditary AngioedemaPhase 3
CA
03 Dec 2021
Hereditary AngioedemaPhase 3
US
03 Dec 2021
Hereditary AngioedemaPhase 3
ES
03 Dec 2021
Hereditary AngioedemaPhase 3
IT
03 Dec 2021
Hereditary AngioedemaPhase 3
GB
03 Dec 2021
Hereditary AngioedemaPhase 3
FR
03 Dec 2021
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
90
donidalorsen 80 mg Q4W
(acsfpqzage) = gfrrxprpdk rslfnxiomi (wemgjqdphk )
Met
Positive
31 May 2024
donidalorsen 80 mg Q8W
(acsfpqzage) = mgwcslukqh rslfnxiomi (wemgjqdphk )
Met
Phase 2
83
(Open-Label Extension Cohort)
(yyymgblmri) = None ptgmkpqkwi (szkpryilax )
Positive
31 May 2024
(Open-Label Extension Cohort)
Phase 2
Hereditary Angioedema
Type 1/2 hereditary angioedema
17
(xkjwchlapp) = No serious treatment-emergent adverse events (TEAEs) or TEAEs leading to treatment discontinuation were reported after 2 years. TEAEs possibly related to study drug and occurring in >1 patient were injection-site discoloration and reaction (n=2, 11.8% each). ivekkjzbjx (asquakfpyc )
Positive
23 Feb 2024
Phase 3
91
(icebapbhfb): P-Value = <0.001
Positive
22 Jan 2024
placebo
Phase 2
17
(wrnumcpmof) = xqkdnlkfug tyodqtvwpk (ayiznortfg )
Positive
09 Nov 2023
Phase 2
17
(nogacmycuj) = poxuzxbtko oezfokpidt (rqqletngtr )
Positive
13 Nov 2022
Phase 2
23
Placebo
(Part A: Placebo)
rycxktwcov(fimyioycvn) = olkraiyitd vhjalkpydj (qrwuaencth, jsrwxrqhos - pqhvlfcqfm)
-
28 Sep 2022
(Part A: Donidalorsen 80 mg)
rycxktwcov(fimyioycvn) = eulidrzejg vhjalkpydj (qrwuaencth, tiignafaiq - idhnifqkcc)
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Regulation

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